NewLink Genetics Corporation Reports First Quarter 2013 Financial Results
"We are looking forward to completing patient accrual for our IMPRESS trial of algenpantucel-L for surgically resected pancreatic cancer. It was also encouraging to see additional clinical trials of both our HyperAcute and IDO product candidates advancing this past quarter," commented Dr.
First Quarter and Recent Accomplishments
- Demonstrated significant progress towards completing enrollment in our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial with algenpantucel-L for patients with surgically resected pancreatic cancer. The primary endpoint for this open label, randomized, multi-centered, 722 patient trial is overall survival. As determined by Special Protocol Assessment (SPA), the first interim analysis will be conducted when 222 deaths are reported for the study.
- Continued patient accrual in our randomized Phase 2B/3 trial comparing tergenpumatucel-L to docetaxel for patients with previously treated non-small cell lung cancer. We expect to add additional sites in the coming months for this trial which has a planned accrual of 240 patients.
- Launched a randomized, placebo controlled Phase 2 study for patients with metastatic breast cancer evaluating the combination of docetaxel with NewLink's most advanced small molecule IDO pathway inhibitor, indoximod. This Phase 2 clinical study will enroll up to 120 patients and follows the successful Phase 1b dose-escalation study of indoximod in patients with advanced solid tumors in which a favorable safety profile and promising early signs of activity were observed.
- Pre-clinical data on
NLG919demonstrating on target anti-tumor effects and synergy with indoximod were presented at the American Association for Cancer Researchannual meeting. Favorable oral bioavailability, pharmacokinetic and pharmacodynamic profiles were also reported. NLG919is NewLink's second small molecule IDO pathway inhibitor and, based on these data, is expected to enter human clinical trials by the end of this year.
Brian Wileyas Vice President Business Development and head of pre-commercialization activities for algenpantucel-L. Mr. Wiley has extensive oncology business development and commercialization experience within the pharmaceutical industry.
- Closed Public Offering with aggregate net proceeds of approximately
$49.0 millionproviding NewLink with resources to advance its lead development programs to their next major data points.
NewLink expects to present at the following conferences:
- Jefferies 2013 Global Healthcare Conference taking place
June 3-6in NYC. American Society of Clinical Oncology (ASCO) May 31 - June 4, 2013in Chicago, IL.
First Quarter 2013 Financial Results
- Cash, cash equivalents and certificates of deposit totaled
$64.0 millionat March 31, 2013.
- Total grant revenues for the first quarter 2013 were
$302,000compared with $471,000for the first quarter 2012.
- Research and development expense for the first quarter 2013 was
$6.3 millioncompared with $3.8 millionfor the first quarter 2012. The $2.5 millionincrease was primarily due to increased manufacturing and clinical trial expense from the same period in 2012.
- General and administrative expense for the first quarter 2013 was
$2.0 millioncompared with $1.5 millionfor the first quarter 2012. This increase was primarily due to increases in personnel related expenses.
- Net loss for the first quarter 2013 was
$7.9 millionor $.33per common share (based on 23.9 million weighted average shares outstanding), compared with $4.8 million, or $.23per common share, for the first quarter 2012 (based on 20.6 million weighted average shares outstanding). The difference in the number of weighted average shares outstanding primarily resulted from NewLink's public offering in February 2013.
NewLink expects to end 2013 with about
NewLink's lead product candidate, algenpantucel-L (HyperAcute® pancreas), is being studied in our IMPRESS (Immunotherapy for Pancreatic Resectable cancer Survival Study) Phase 3 trial for patients with surgically resected pancreatic cancer (under a Special Protocol Assessment with the U.S.
NewLink is also actively developing two small-molecule, IDO (indoleamine-(2, 3)-dioxygenase) pathway inhibitors. The most advanced is indoximod, an orally bioavailable product candidate, that is being studied in various chemotherapy and immunotherapy combination clinical studies. NewLink's second IDO pathway inhibitor,
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan,""target," "potential," "will,""could," "should,""seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: NewLink's financial guidance for 2013; the timing for completion of enrollment of our Phase 3 clinical trial for our HyperAcute Pancreas cancer immunotherapy; the timing of release of clinical data from ongoing clinical studies; its plans related to moving additional indications into clinical development; NewLink's future financial performance, results of operations or sufficiency of capital resources to fund its operating requirements; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended
|Condensed Consolidated Statement of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended|
|Research and development||6,343||3,830|
|General and administrative||2,001||1,458|
|Loss from operations||(8,042||)||(4,817||)|
|Other (expense) income, net||108||(25||)|
|Net loss attributable to NewLink||$||(7,934||)||$||(4,842||)|
|Net loss per common share, basic and diluted||$||(0.33||)||$||(0.23||)|
|Weighted average common shares outstanding||23,860,469||20,613,146|
|Condensed Consolidated Balance Sheets|
|(In thousands, except share and per share data)|
|Cash, cash equivalents and certificates of deposit||$||64,025||$||21,744|
|Prepaid expenses and other current assets||1,741||1,645|
|Total current assets||65,766||23,389|
|Property and equipment, net||5,889||6,040|
|Liabilities and Equity|
|Accounts payable and accrued expenses||$||2,880||$||2,631|
|Other current liabilities||177||204|
|Total current liabilities||3,141||2,919|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||1,136||1,178|
|Total long-term liabilities||8,520||8,583|
|Additional paid-in capital, net||172,469||122,514|
|Deficit accumulated during the development stage||(112,731||)||(104,797||)|
|Total liabilities and equity||$||71,655||$||29,429|
Chief Financial Officer
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